Recent Articles in Gov't & Regulatory

China has added 119 new therapies to its National Reimbursement Drug List after drugmakers from China and the rest of the world accepted price reductions of 51% to be included. Although the price cuts were painful, they were 10% less severe than last year. The negotiations took longer than expected. The additions to the NRDL include three PD-1 inhibitors from China biopharmas, bringing the total to four. PD-1 products from BeiGene, Jiangsu Hengrui Medicine and Shanghai Junshi Biosciences join an Innovent PD-1 checkpoint inhibitor, the first China-developed offering in the category. More details....

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The Phase I trade agreement between the US and China contains several important rules that are important for novel biopharma companies, with China agreeing to new rules for resolving pharmaceutical patent disputes, patent term extension and counterfeit medicines. China will warn patent holders when a generic pharma seeks regulatory approval for generic or biosimilar versions of a patent-protected drug, and to do so while the patent holder has time to respond. The agreement also contains six pages of rules for resolving disputes. The agreement does not, however, specify how long novel drugs will be protected by patents. More details....

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Jiankui He, the Shenzhen scientist who used CRISPR-Cas9 gene editing to alter the embryos of seven IVF patients, was sentenced to three years in prison and a fine of $430,000. Dr. He maintains he used gene editing to disable the CCR5 gene that allows HIV to enter cells. The researcher was accused of avoiding standard procedures for protecting patients in an attempt to become the first scientist to perform the procedure. Dr. He pleaded guilty and is banned for life from providing assisted reproductive services. More details....

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China's National Healthcare Security Administration announced that 70 drug have been added to the list of drugs eligible for insurance reimbursement after biopharmas agreed to price cuts that averaged 61%. Two new products from western companies, anemia treatment roxadustat from AstraZeneca and lung cancer therapy alecensa from Roche, are now covered by China's insurance plan. And China's domestic PD-1 therapy for Hodgkin’s lymphoma, Tyvyt, co-developed by Suzhou's Innovent and Eli Lilly, was also added, the first PD-1 on the list, even though China has five approved PD-1/PD-L1 products, including two from the US. By including Tyvyt in the reimbursement list, the NHSA may have given Tyvyt a big boost in early market positioning. More details....

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